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Reports of late thrombosis after drug-eluting stent (DES) implantation have sparked numerous mainstream-press reports. An FDA advisory panel was recently convened to study the issue; an official FDA response is pending. Data from four recent studies are among the evidence for the FDA to consider in assessing the risks and benefits of widely used DES technology.
One research group synthesized data from 14 randomized trials, involving 6675 patients, in which DES (47% sirolimus-eluting; 53% paclitaxel-eluting) was compared with bare-metal stents (BMS). Thrombosis incidence, per 1000 patients treated, was similar between DES and BMS within 30 days after implantation (4.4 and 5.0 events, respectively), but incidence was significantly greater with…